메뉴 건너뛰기




Volumn 2, Issue 3, 2012, Pages 226-237

Validated gradient stability indicating HPLC method for determining Diltiazem Hydrochloride and related substances in bulk drug and novel tablet formulation

Author keywords

Benzodiazepine; Diltiazem Hydrochloride; HPLC; ICH guidelines; Related substances; Stability indicating

Indexed keywords

ACETONITRILE; DILTIAZEM; DILTIAZEM IMPURITY A; DILTIAZEM IMPURITY B; DILTIAZEM IMPURITY D; DILTIAZEM IMPURITY E; DILTIAZEM IMPURITY F; DILTIAZEM SULFOXIDE; DRUG METABOLITE; TRIETHYLAMINE; UNCLASSIFIED DRUG;

EID: 84925835428     PISSN: 20951779     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpha.2012.01.003     Document Type: Article
Times cited : (24)

References (29)
  • 2
    • 0021796829 scopus 로고
    • Diltiazem. A review of its pharmacological properties and therapeutic efficacy
    • M. Chaffman, and R.N. Brodgen Diltiazem. A review of its pharmacological properties and therapeutic efficacy Drugs 29 1985 387 454
    • (1985) Drugs , vol.29 , pp. 387-454
    • Chaffman, M.1    Brodgen, R.N.2
  • 3
    • 0025330414 scopus 로고
    • A reappraisal of its pharmacological properties and therapeutic use
    • M.M. Bukley, S.M. Grant, and K.L. Goa A reappraisal of its pharmacological properties and therapeutic use Drugs 39 1990 757 806
    • (1990) Drugs , vol.39 , pp. 757-806
    • Bukley, M.M.1    Grant, S.M.2    Goa, K.L.3
  • 4
    • 0004144140 scopus 로고
    • 30th ed. The Pharmaceutical Press London (p. 354)
    • W. Martindale The Extra Pharmacopoeia 30th ed. 1993 The Pharmaceutical Press London (p. 354)
    • (1993) The Extra Pharmacopoeia
    • Martindale, W.1
  • 8
    • 84925836534 scopus 로고    scopus 로고
    • Monograph of Diltiazem Hydrochloride
    • Medicine and Healthcare Products Regulatory Agency, London
    • Monograph of Diltiazem Hydrochloride, British Pharmacopoeia, vol. 1-2, Medicine and Healthcare Products Regulatory Agency, London, 2009.
    • (2009) British Pharmacopoeia , vol.1-2
  • 10
    • 0027318839 scopus 로고
    • Selective spectrophotometric determination of diltiazem hydrochloride in tablets
    • B.V. Kamath, K. Shivram, and A.C. Shah Selective spectrophotometric determination of diltiazem hydrochloride in tablets J. Pharm. Biomed. Anal. 11 1993 407 412
    • (1993) J. Pharm. Biomed. Anal. , vol.11 , pp. 407-412
    • Kamath, B.V.1    Shivram, K.2    Shah, A.C.3
  • 11
    • 0029592219 scopus 로고
    • Visible spectrophotometric methods for the determination of diltiazen hydrochloride
    • C.S.P. Sastri, K. Sreedhar, and M.N. Reddy Visible spectrophotometric methods for the determination of diltiazen hydrochloride Indian J. Pharm. Sci. 57 1995 170 179
    • (1995) Indian J. Pharm. Sci. , vol.57 , pp. 170-179
    • Sastri, C.S.P.1    Sreedhar, K.2    Reddy, M.N.3
  • 12
    • 0023256852 scopus 로고
    • Assay of diltiazem and deacetyldiltiazem by capillary gas chromatography
    • O. Grech-Belanger, E. Leboeuf, and S. Langlois Assay of diltiazem and deacetyldiltiazem by capillary gas chromatography J. Chromatogr. B 417 1987 89 98
    • (1987) J. Chromatogr. B , vol.417 , pp. 89-98
    • Grech-Belanger, O.1    Leboeuf, E.2    Langlois, S.3
  • 13
    • 0032549606 scopus 로고    scopus 로고
    • High-performance thin-layer chromatographic determination of diltiazem hydrochloride as bulk drug and in pharmaceutical preparations
    • P.V. Devarajan, and V.V. Dhavse High-performance thin-layer chromatographic determination of diltiazem hydrochloride as bulk drug and in pharmaceutical preparations J. Chromatogr. B 706 1998 362 366
    • (1998) J. Chromatogr. B , vol.706 , pp. 362-366
    • Devarajan, P.V.1    Dhavse, V.V.2
  • 14
    • 0023097960 scopus 로고
    • General method for the analysis of pharmaceutical dosage forms by high-performance liquid chromatography
    • A.S. Sidhu, J.M. Kennedy, and S. Deeble General method for the analysis of pharmaceutical dosage forms by high-performance liquid chromatography J. Chromatogr. 391 1987 233 239
    • (1987) J. Chromatogr. , vol.391 , pp. 233-239
    • Sidhu, A.S.1    Kennedy, J.M.2    Deeble, S.3
  • 15
    • 0025372427 scopus 로고
    • High-performance liquid chromatographic determination of diltiazem hydrochloride in tablets
    • Y. Shah, S. Khanna, and V.S. Dighe High-performance liquid chromatographic determination of diltiazem hydrochloride in tablets Indian Drugs 27 1990 363
    • (1990) Indian Drugs , vol.27 , pp. 363
    • Shah, Y.1    Khanna, S.2    Dighe, V.S.3
  • 16
    • 0001204532 scopus 로고
    • Kapillarelektrophorese: Methoden und Möglichkeiten
    • H. Engelhardt, W. Beck, and J. Kohr Kapillarelektrophorese: methoden und Möglichkeiten Angew. Chem. 105 1993 659 680
    • (1993) Angew. Chem. , vol.105 , pp. 659-680
    • Engelhardt, H.1    Beck, W.2    Kohr, J.3
  • 17
    • 19544363538 scopus 로고    scopus 로고
    • Analysis of diltiazem in Lipoderm® transdermal gel using reversed-phase high-performance liquid chromatography applied to homogenization and stability study
    • J.L. Buur, R.E. Baynes, and J.L. Yeatts Analysis of diltiazem in Lipoderm® transdermal gel using reversed-phase high-performance liquid chromatography applied to homogenization and stability study J. Pharm. Biomed. Anal. 38 2005 60 65
    • (2005) J. Pharm. Biomed. Anal. , vol.38 , pp. 60-65
    • Buur, J.L.1    Baynes, R.E.2    Yeatts, J.L.3
  • 18
    • 34547700800 scopus 로고    scopus 로고
    • A validated method for the analysis of Diltiazem in raw materials and pharmaceutical formulations by RP-HPLC
    • N. Sultana, M.S. Arayne, and N. Shafi A validated method for the analysis of Diltiazem in raw materials and pharmaceutical formulations by RP-HPLC Pak. J. Pharm. Sci. 20 2007 279 284
    • (2007) Pak. J. Pharm. Sci. , vol.20 , pp. 279-284
    • Sultana, N.1    Arayne, M.S.2    Shafi, N.3
  • 19
    • 0036027718 scopus 로고    scopus 로고
    • Simultaneous enantioseparation of cis-diltiazem hydrochloride and its metabolite cis-desacetyldiltiazem using high-performance liquid chromatography and capillary electrophoresis
    • B. Chankvetadze, I. Kartozia, and G. Blaschke Simultaneous enantioseparation of cis-diltiazem hydrochloride and its metabolite cis-desacetyldiltiazem using high-performance liquid chromatography and capillary electrophoresis J. Pharm. Biomed. Anal. 27 2002 161 166
    • (2002) J. Pharm. Biomed. Anal. , vol.27 , pp. 161-166
    • Chankvetadze, B.1    Kartozia, I.2    Blaschke, G.3
  • 20
    • 0028805940 scopus 로고
    • Development and validation of a bioanalytical method for the quantification of diltiazem and desacetyldiltiazem in plasma by capillary zone electrophoresis
    • C. Coors, H.G. Schultz, and F. Stache Development and validation of a bioanalytical method for the quantification of diltiazem and desacetyldiltiazem in plasma by capillary zone electrophoresis J. Chromatogr. A 717 1995 235 243
    • (1995) J. Chromatogr. A , vol.717 , pp. 235-243
    • Coors, C.1    Schultz, H.G.2    Stache, F.3
  • 21
    • 0025370450 scopus 로고
    • Separation and determination of lipophilic corticosteroids and benzothiazepin analogues by micellar electrokinetic chromatography using bile salts
    • H. Nishi, T. Fukuyama, and M. Matsuo Separation and determination of lipophilic corticosteroids and benzothiazepin analogues by micellar electrokinetic chromatography using bile salts J. Chromatogr. 513 1990 279
    • (1990) J. Chromatogr. , vol.513 , pp. 279
    • Nishi, H.1    Fukuyama, T.2    Matsuo, M.3
  • 22
    • 0041825163 scopus 로고    scopus 로고
    • High-performance liquid chromatography-mass spectrometry analysis of diltiazem and 11 of its phase i metabolites in human plasma
    • E. Molden, G.H. Boe, and H. Christensen High-performance liquid chromatography-mass spectrometry analysis of diltiazem and 11 of its phase I metabolites in human plasma J. Pharm. Biomed. Anal. 33 2003 275 285
    • (2003) J. Pharm. Biomed. Anal. , vol.33 , pp. 275-285
    • Molden, E.1    Boe, G.H.2    Christensen, H.3
  • 23
    • 15744391897 scopus 로고    scopus 로고
    • Analysis of diltiazem and its related substances by HPLC and HPLC/MS
    • M.G. Quaglia, E. Donati, and S. Fanali Analysis of diltiazem and its related substances by HPLC and HPLC/MS J. Pharm. Biomed. Anal. 37 2005 695 701
    • (2005) J. Pharm. Biomed. Anal. , vol.37 , pp. 695-701
    • Quaglia, M.G.1    Donati, E.2    Fanali, S.3
  • 24
    • 0024211797 scopus 로고
    • Stability-indicating high performance liquid chromatographic determination of diltiazem hydrochloride
    • M.E. Abdel-hamid, M.S. Suleiman, and N.M. Najib Stability-indicating high performance liquid chromatographic determination of diltiazem hydrochloride Anal. Lett. 21 1988 2263 2275
    • (1988) Anal. Lett. , vol.21 , pp. 2263-2275
    • Abdel-Hamid, M.E.1    Suleiman, M.S.2    Najib, N.M.3
  • 25
    • 0026643756 scopus 로고
    • Stability-indicating high performance liquid chromatographic method for the assay of diltiazem hydrochloride in tablets
    • K. Shivram, A.C. Shah, and BL Newalkar Stability-indicating high performance liquid chromatographic method for the assay of diltiazem hydrochloride in tablets J. Liq. Chromatogr. Relat. Technol. 15 1992 2417 2422
    • (1992) J. Liq. Chromatogr. Relat. Technol. , vol.15 , pp. 2417-2422
    • Shivram, K.1    Shah, A.C.2    Newalkar, B.L.3
  • 26
    • 0024509654 scopus 로고
    • High performance liquid chromatography method for assay of diltiazem hydrochloride and its related compounds in bulk drug and finished tablets
    • P.M. Lacroix, N. Beaulieu, and T.D. Cyr High performance liquid chromatography method for assay of diltiazem hydrochloride and its related compounds in bulk drug and finished tablets J. Pharm. Sci. 78 3 1989 243 246
    • (1989) J. Pharm. Sci. , vol.78 , Issue.3 , pp. 243-246
    • Lacroix, P.M.1    Beaulieu, N.2    Cyr, T.D.3
  • 29
    • 0037097780 scopus 로고    scopus 로고
    • Development of stability indicating assay methods - A critical review
    • S. Singh, and M. Bakshi Development of stability indicating assay methods - a critical review J. Pharm. Biomed. Anal. 28 2002 1011 1040
    • (2002) J. Pharm. Biomed. Anal. , vol.28 , pp. 1011-1040
    • Singh, S.1    Bakshi, M.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.